Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
186
Countries
5
Sites
17
Relapsed or refractory B-cell malignancies: chronic lymphocytic leukemia (CLL), including RT (Richter’s Transformation) from CLL, mantle-cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL)
Key facts
- Sponsor
- Exscientia AI Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 17 Feb 2025 → ongoing
- Decision date (initial)
- 2026-05-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or refractory B-cell malignancies: chronic lymphocytic leukemia (CLL), including RT (Richter’s Transformation) from CLL, mantle-cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10008978 | Chronic lymphocytic leukemia refractory | 10029104 |
| 20.0 | PT | 10076596 | Marginal zone lymphoma | 100000004864 |
| 21.0 | PT | 10012822 | Diffuse large B-cell lymphoma refractory | 100000004864 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
| 21.1 | PT | 10026801 | Mantle cell lymphoma refractory | 100000004864 |
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
| 21.1 | PT | 10077533 | Marginal zone lymphoma recurrent | 100000004864 |
| 27.0 | PT | 10085128 | Follicular lymphoma | 100000004864 |
| 20.0 | PT | 10058728 | Richter's syndrome | 100000004864 |
| 20.0 | PT | 10077534 | Marginal zone lymphoma refractory | 100000004864 |
| 21.0 | PT | 10026800 | Mantle cell lymphoma recurrent | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Exscientia AI Limited
- Sponsor organisation
- Exscientia AI Limited
- Address
- Level 3, 5 West Victoria Dock Road, 1 River Crescent 5 West Victoria Dock Road 1 River Crescent
- City
- Dundee
- Postcode
- DD2 1UJ
- Country
- United Kingdom
Scientific contact point
- Organisation
- Exscientia AI Limited
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- Exscientia AI Limited
- Contact name
- Clinical Trial Information Desk
Locations
5 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 20 | 3 |
| Greece | Authorised, recruitment pending | 16 | 3 |
| Poland | Authorised, recruitment pending | 20 | 4 |
| Romania | Authorised, recruitment pending | 30 | 2 |
| Spain | Ongoing, recruiting | 15 | 5 |
| Rest of world
United Kingdom
|
— | 85 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Service d’Hématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Regional De Marseille
Centre d'Essais Précoces en Cancérologie de Marseille, 264 Rue Saint Pierre, 13005, Marseille
Institut Bergonie
Service d’Hématologie, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
General University Hospital Of Patras
Hematology Department/Bone Marrow Transplantation Unit, Department of Internal Medicine, Rio, 265 04, Patras
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Clinic, Exochi, 570 10, Thessaloniki
Laiko General Hospital Of Athens
Department of Haematology and Bone Marrow Transplantation Unit, Agiou Thoma (goudi) 17, 115 27, Athens
Aidport Sp. z o.o.
n/a, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
PRATIA MCM Kraków
n/a, ul. Pana Tadeusza 2, 30-727, Kraków
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Oddział Wieloprofilowy Zachowawczy, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematologii Ogólnej i Chorób Wewnętrznych, Ul. Pabianicka 62, 93-513, Lodz
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
ARENSIA Exploratory Medicine SRL in collaboration with ”Prof.Dr.Ion Chiricuta” Institute of Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Arensia Clinics S.R.L.
ARENSIA Exploratory Medicine S.R.L in collaboration with ARENSIA Clinics SRL, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Beata Maria Ana
Hematology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Hm Sanchinarro
Hematology, Calle Ona 10, 28050, Madrid
MD Anderson Cancer Center
Hematology, Calle De Arturo Soria Nº 270, 28033, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-02-17 | 2025-03-31 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-17 | Spain | Acceptable 2025-01-23
|
2025-01-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-21 | Spain | Acceptable 2025-01-23
|
2025-03-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-21 | Spain | Acceptable | 2025-04-15 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-20 | Spain | Acceptable | 2025-05-20 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-06-16 | Spain | Acceptable | 2025-06-16 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-21 | Spain | Acceptable | 2025-07-21 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-26 | Spain | Acceptable 2025-12-01
|
2026-01-11 |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2026-02-17 | 2026-04-27 | ||
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2026-02-18 | 2026-05-11 | ||
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2026-02-18 | 2026-05-18 | ||
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2026-02-18 | Acceptable 2025-12-01
|
2026-05-15 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-18 | Spain | Acceptable | 2026-03-04 |